Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 15 November 2013 | By Alexander Gaffney, RAC,
Both the House of Representatives and Senate have now given their assent to a bill that would allow patients infected with the Human Immunodeficiency Virus (HIV) to donate organs to other HIV-positive individuals, a major reversal of longstanding policy that now awaits President Barack Obama's signature.
Current tissue, cellular and organ donations policies in the US are geared toward the absolute minimization of risk with respect to the transmission of communicable diseases. At present, authorities such as the Red Cross test donated products for HIV (Types 1 and 2), hepatitis B and C, the human T-lymphotropic virus and the West Nile virus.
The intent is to prevent patients from accidentally being exposed to the diseases, particularly in the wake of many hemophilia patients being exposed to HIV in the 1980s due to lax testing standards.
But organs are subject to a unique restriction under the National Organ Transplant Act of 1984, which prohibits the donation of HIV-infected organs. Critics have long contended that the ban, while well-intentioned at the time, has outlived its useful purpose and is instead now harming patients.
For example, consider two patients with HIV: One about to die, and the other in need of a transplant but on a waiting list. Under current policy, if the first patient dies, his organs would be unable to be used. That leaves the second patient to have to wait even longer for other organs, and denies someone else the ability to receive those organs once she does receive them.
And the need appears to be greater than ever before. Getting HIV may once have been akin to a death sentence, but many patients are now facing the prospect of living longer lives than the useful lives of some of their organs.
The HIV Organ Policy Equity (HOPE) Actlooks to solve the problem by permitting HIV+ patients to donate to other HIV+ patients.
The bill, sponsored by Sen. Barbara Boxer (D-CA) and co-sponsored by 15 other legislators, passed the Senate in June 2013, and on 12 November 2013 passed the House of Representatives in a voice vote. The bill was presented to President Barack Obama on 14 November 2013, and now awaits his signature before it becomes law.
The relatively short bill would only permit organs to be donated to HIV+ individuals if they are participating in clinical research approved by an institutional review board, though regulators may waive this requirement if they feel it "is no longer warranted."
The bill would not immediately go into effect. Instead, regulators will have two years in which to promulgate regulations establishing the process by which the transplants would take place, which would most likely include standards and safeguards for ensuring that HIV-positive organs don't enter into the non-infected supply chain.
While passage of the bill was hailed by noted bioethicist Arthur Caplan, director of the Division of Medical Ethics in the Department of Population Health at NYU Langone Medical Center, he said legislators would have done well to consider extending its provisions even further.
"This is a good step forward, but one wonders whether limiting the potential recipients to HIV+ folks is itself wise," he said in a posting on the Harvard Bill of Health blog. "I can easily imagine circumstances where an individual who faces death would prefer an HIV+ organ even if it will carry with it a significant chance of HIV infection."
In addition, Caplan raised the prospect of potential lawsuits in the future. "One might indeed wonder if, in some weird way, the bill now creates a disability discrimination (I say that because the Supreme Court has in its jurisprudence treated HIV as capable of causing a major life impairment under the Americans with Disabilities Act) in favor of those with HIV, because only they are potentially eligible for a certain pool of organs that may become available," he observed. Even if that winds up not being the case, "it is at least quite curious," he added.
HIV Organ Policy Equity (HOPE) Act
Tags: HIV, Organ
Regulatory Focus newsletters
All the biggest regulatory news and happenings.